UMIN-CTR Clinical Trial

Basic information
Public title	The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Acronym	The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Scientific Title	The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Scientific Title:Acronym	The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Region	Japan

Condition
Condition	Advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of nintedanib and carboplatin plus paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of treatment-related ILD
Key secondary outcomes	RR: response rate OS: overall survival PFS: progression free survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	carboplatin AUC6 D1 paclitaxel 200mg/m D1 tryweekly 4cycle nintedanib 150mg twice daily
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed non-small-cell lung cancer 2) stage3B, stage4 or postoperative recurrence NSCLC 3) Idiopathic interstitial pneumonia 4) performance status 0 or 1 5) Age>=20 6) Measurable lesion 7) Adequate organ function WBC>=3000/mm3 and neutrophil count >=1500/mm3 Hgb>=9.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<2.5*ULN ALT=<2.5*ULN, CRN=<1.5*ULN PaO2>=60.0 torr or SpO2>=93.0 % 8) Life expectancy > 8 weeks 9) Written informed consent
Key exclusion criteria	1)Uncotrollable angiona pectorias, cardian infarction, haear failure, diabetes mellitus, hypertension 2) Using prednisolone >10mg/day 3) Active infection 4) Active double cancers 5) symptomatic brain metastasis 6) Patients with uncontrolled pleural or pericardial effusion, or ascites 7) pregnancy 8) Patient with a history of allergy to CBDCA, PTX and nintedanib 9) Inappropriate patients in this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name sadatomo Middle name Last name Tasaka
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	0368562
Address	Zaifu-cho 5, Hirosaki, Japan
TEL	0172395468
Email	xyghx335@gmail.com

Public contact
Name of contact person	1st name Hisashi Middle name Last name Tanaka
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	0368056
Address	Zaifu-cho 5, Hirosaki, Japan
TEL	+81-172-33-5111
Homepage URL
Email	xyghx335@gmail.com

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Hirosaki
Address	5 zaifucho Hirosaki Japan
Tel	0172335111
Email	rinri@hirosaki-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	弘前大学医学部附属病院（青森県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 23 Day
Date of IRB	2016 Year 04 Month 04 Day
Anticipated trial start date	2016 Year 04 Month 04 Day
Last follow-up date	2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 23 Day
Last modified on	2021 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024894